a study of oral gimatecan in platinum-resistant epithelial ovarian, fallopian tube or peritoneal cancer

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: this phase ii clinical trial studies the safety and effect of gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer. the chemotherapy will be given every four weeks.this study is a single-arm, multi-center research design.

the study had 3 phases: screening phase, treatment phase and follow-up phase. during the treatment phase, the drug will continue to be administered until the progression of disease, complete remission , unacceptable toxicity.

Eligibility criteria:
inclusion criteria: 1. the subjects were able to understand the informed consent, voluntarily participate in and sign the informed consent, with good compliance and cooperation with follow-up. 2. a histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer. 3. previous systematic treatment ≤ 2 lines, and progression in platinum based regimens or recurrence within 6 months after the end of platinum regimen. 1) imaging progression of recurrence and progression should be clearly recorded;2) neoadjuvant + adjuvant chemotherapy with platinum regimen ≥ 6 cycles, and platinum regimen after recurrence / progression ≥ 4 cycles;3) if there is progression during the treatment of platinum based regimen, the treatment cycle is not limited;4) recurrence / progression within 6 months after the end of neoadjuvant / adjuvant therapy is considered to have received the first-line systematic treatment. 4. measurable cancer lesion according to response evaluation criteria in solid tumors (recist) v1.1; 5. ≥18 years old; 6. eastern cooperative oncology group(ecog) performance status score 0-1; 7. estimated life expectancy \>3 months; 8. the function of important organs meets the following requirements: 1. white blood cell count (wbc) ≥ 3.0×109/l, absolute neutrophil count (anc) ≥ 1.5×109/l, platelets ≥ 100×109/l, hemoglobin ≥ 90g/l; 2. alt, ast≤ 2.5×uln; liver metastasis: alt、ast≤ 5.0×uln; 3. serum albumin ≥ 28g/l; 4. total bilirubin ≤ 1.5×uln; 5. serum creatinine ≤ 1.5×uln, creatinine clearance rate ≥60 ml/min; 6. pt≤ 1.5×uln; 9. the subjects had no history of allergy to camptothecin or its components; 10. non surgical sterilization or female subjects of childbearing age need to use a medically approved contraceptive method after signing the informed consent, during the study treatment period and within 6 months after the end of the study treatment period; non surgical sterilization female subjects of childbearing age must have negative blood hcg test within 3 days before entering the study; and they must be in non lactation period. 11. taking drugs orally; 12. the subjects had recovered and treatment will start more than 4 weeks after the end of previous surgery, chemotherapy, targeted therapy and radiotherapy. exclusion criteria: 1. subjects who have been treated previously with topotecan, irinotecan or other topoisomerase i inhibitors; 2. other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan; 3. within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment; 4. subjects with a history of major gastrointestinal surgery (e.g., total gastrectomy, small bowel resection) or gastrointestinal dysfunction that may alter drug absorption and activity in vivo; 5. severe cardiovascular disease, such as nyha grade 3-4 heart failure; 6. patients who have been treated previously with intravenous or oral drugs that affect cyp isoenzymes within 7 days prior to the first dose of the investigational drug gimatecan; 7. a history of immunodeficiency (including a positive hiv test result);presence of active hepatitis b , hepatitis c (positive for hepatitis c antibody, and hcv-rna levels higher than the lower limit of the assay); 8. pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment; 9. subjects with hereditary or acquired bleeding tendency (hemophilia, thrombocytopenia, etc.), interstitial pneumonia or pulmonary fibrosis, and active tuberculosis (whether or not treated) in the past year; 10. vaccinated with live attenuated vaccine within 4 weeks; 11. subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan; 12. subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis. 13. other considered unsuitable for the study.

Keywords: epithelial ovarian, fallopian tube or peritoneal cancer platinum resistant chemotherapy gimatecan